Associate Manufacturing - Bulk Drug Substance Downstream - Days

Amgen • Holly Springs, NC

6h • Onsite

About The Position

Amgen is seeking an Associate in the manufacturing organization at Amgen North Carolina (ANC). This role supports critical 24/7 manufacturing operations, working a 12-hour 2-2-3 schedule from 5:45 am to 6:15 pm. Associates will perform manufacturing operations in the downstream area, responsible for the production of cGMP (Current Good Manufacturing Practices) drug substances. With general direction, the Associate will support all floor operations in accordance with cGMP practices. This role requires regular attendance and the ability to work assigned 12-hour shifts, including during inclement weather, some holidays, and requested overtime to support 24/7 operations. Amgen's newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility, combines disposable technologies with traditional stainless-steel equipment for maximum flexibility. The facility integrates sustainability innovations to reduce carbon and waste, aligning with Amgen's goal to be a carbon-neutral company by 2027.

Requirements

• High School/GED + 2 years manufacturing and/or other regulated environment experience OR Associate’s Degree + 6 months manufacturing and/or other regulated environment experience OR Bachelor’s Degree
• Excellent verbal and written communication
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
• An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Nice To Haves

• Completion of NC BioWorks Certification Program
• Experience in a regulated industry such as biotechnology or pharmaceutical
• Basic understanding and process experience in a cGMP manufacturing facility

Responsibilities

• Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance.
• Assures proper gowning and aseptic techniques are always followed.
• Performs hands-on downstream bio-tech operations (Column Chromatography, Tangential Flow Filtration among others) including set-up, cleaning, sanitization, monitoring of equipment and assigned area.
• Runs and monitors critical process tasks per assigned procedures.
• Performs in-process sampling, operates analytical equipment, and completes process documentation (Electronic Batch Records [EBRs]).
• Completes washroom activities: cleaning equipment, small to large scale, used in production activities.
• Initiates and owns manufacturing-related process deviations.
• Identifies and escalates issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions.
• Performs documentation for assigned functions (i.e., equipment logs, EBRs).
• Collaborates as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities.
• Maintains an organized, clean, and workable space.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED